Site Care Partner I

5-6 years

Not Disclosed

India Remote

10 Feb. 10, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Site Care Partner I
Location: India (Remote)
Job ID: R0000029686
Category: Clinical Trials
Date Posted: 01/07/2025

Job Purpose

The Site Care Partner I is responsible for the site start-up and activation processes, including site qualification, coordination, and ensuring site readiness for study activities. This role is integral to maintaining effective site relationships, overseeing study delivery, and supporting the study lifecycle from initiation to close-out.

Key Responsibilities

Site Start-Up and Activation

Qualify and activate assigned sites based on GSSO site strategies.
Support country and site selection activities, including reviewing and assessing draft potential site lists and providing PTA output.
Collaborate with stakeholders for country/regional input on country outreach surveys, protocol feasibility, country SOC, and medical practices.
Maintain thorough knowledge of assigned study protocols.
Manage study start-up activities, including PTA, site activation checklist coordination, ICD finalization, and SIV (as applicable).
Ensure timely completion of site initiation activities, including training, documentation, and system updates (e.g., PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF).
Support ICD review and deployment when applicable.

Study Support and Delivery

Provide operational support to resolve site-level issues related to study delivery (e.g., vendor, site contracts, and payment issues).
Oversee and ensure the effective recruitment of sites, managing enrollment support and addressing recruitment issues.
Maintain regular communication with investigator sites to monitor recruitment and data entry timelines, ensuring progress toward study goals.
Partner with local RA/CTRO/SAP to ensure timely completion of country/local registry requirements (when applicable).

Study Conduct and Close-Out

Act as the operational point of contact for site-level inquiries and escalate as needed.
Review Site Monitoring Reports and support the site with document revisions and submissions.
Maintain system management at the site level, ensuring alignment across platforms (e.g., EDC, Shared Investigator Platform, Site Profile).
Regularly update site assessments and implement necessary changes for continuity and contingency plans.
Review and manage discrepancies between site and client practices, coordinating with study management as necessary.
Monitor site deliverables, such as data cuts, interim analyses, and database locks, ensuring data is up-to-date.
Proactively identify and mitigate risks according to the study oversight plan.

Site Performance and Relationship Management

Drive improvements in monitoring efficiencies and best practices.
Support decentralized capabilities at investigator sites, including home health, ePRO, and DTP.
Strengthen investigator/site relationships and address training or compliance concerns with the Country Trials Manager and Study Management.
Provide local intelligence regarding site performance and practices.
Collaborate with Study Operations Managers and Global Study Managers to define local requirements for investigational medical product import/export.

Qualifications

Training and Education

Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience (minimum of 5 years’ experience).
Proficiency in the local language is preferred; English proficiency is required.

Prior Experience

Demonstrated experience in site management and monitoring.
Proven experience in site start-up activities and site activation.
Experience in study conduct and close-out activities.
Knowledge of quality and regulatory requirements specific to applicable countries.

Technical Competencies

Strong knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other relevant regulatory requirements.
Proficient computer skills and ability to adapt to new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage up to 75% travel regularly.
Strong networking and relationship-building skills.
Capability to manage cross-functional relationships effectively.
Knowledge of country-specific GCP requirements and deviations from Client Procedures.

Behavioral Competencies

Ability to overcome barriers encountered during the implementation of new processes and systems.
Effective relationship-building with investigator site staff and other stakeholders.
Strong verbal and written communication skills, particularly in liaising with internal and external teams.

This position offers a remote working opportunity for individuals with a background in site management, clinical trials, and study coordination, enabling them to drive site performance and ensure the timely and efficient delivery of study objectives.

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